Direct Staffing

Sr. Manager, Packaging Project Management Head

Pharmacy Biotech

Job Description

This position manages the Great Valley site Packaging Project Management group. This is comprised of Clinical Supplies Packaging Managers (CSPM) and the Packaging Instructions group. CSPM work with the Trial Supply Operations Manager and Supply Alignment Managers to ensure study package feasibility is conducted to meet the customers' requirements and ensure product availability for worldwide shipment. The CSPM role coordinates the process to produce and make available fit-use investigational product within the global Clinical Supplies SCP. The complexity of the clinical trials packaging process requires the individual in this position to be clinical supplies packaging operations project oriented. The position requires a manager who is hands-on, focused, detail oriented, customer driven, and capable of functioning in a high pressure, schedule driven environment. The ability of this person to motivate the CSPM to excel in their performance is essential. This position also supports the other Management functions in the local Clinical Supplies SCP. This position will be required to deliver supply chain efficiency through continued business process improvement.

Major Duties & Responsibilities: Manage, monitor and evaluate the performance of the Great Valley Packaging Project Management group. Manage the CSPM in order to ensure that quality packaged investigational supplies are available on the agreed availability date. Manage the Packaging Instructions team to ensure the translation of the packaging designed by CSPM and Technical Packaging Coordinators into operational routines and within NASCA, if appropriate. Works with management to develop and support global harmonization of process and practice in the Clinical Supplies SCP. Ensure the operational lead and coordination between all the different entities of the Packaging site to guarantee the correct alignment towards the SCP objectives, if appropriate. Ensure SMs coordination with other interface groups in CS SCP (Packaging and Distribution Operations, SCA) to develop production plans and deliver to meet the overall program objectives of the portfolio. Overall responsibility for the label translation process. Maintain a strong liaison with all departmental support groups. Ensure that team ties with those involved in the design, budgeting, planning, production and release of clinical supplies is constantly maintained. Continually build, reevaluate and maintain the relationship with production team. Review and evaluate reports related to CS SCP operations, e.g. production, planning and resource reports, on a regular basis. Ensure that all project forecasting is accurate and current in all scheduling and budget systems. Perform regular projects review with SMs to monitor Master Study Schedule. Ensure all activity supports the packaging operations in maintaining budget and competitiveness compared to external contractors. Evaluate clinical supply processes and make improvement recommendations. Ensure the harmonized use and development of CS SCP's standard catalogue of packaging solutions. Major Challenges/Problems: Supply availability dates are dependent on many links in the clinical and supply chain. Management will work with these groups through the Solution Manager to coordinate efforts and target the agreed upon availability date. A team approach is essential in meeting the challenges and problems. The Manager must be vigilant in monitoring the performance of the CSPMs and recognizing the potential need for refresh or new-skills training. Key Internal/External Relationships: All R&D departments are vital in supporting the success of the Clinical Supplies SCP and the Company. Frequent contact with PSD, QC, Q&C, worldwide CS SCP and Regulatory colleagues must be maintained. Decision Making Authority: This position has the authority to make decisions that affect the daily operation of the department. Major personnel and policy decisions are recommended and discussed with the Packaging Site Head before they are pursued and implemented.

Qualifications

Formal Education And Experience Required: Bachelor of Science (BS) degree required, preferably in Pharmacy, Nursing or health-related field with at least 8 to 10 pharmaceutical industry experience or Masters of Science (MS) degree required, preferably in Pharmacy, Nursing or health-related field with 6 to 8 years pharmaceutical industry experience. Experience must include a minimum of 5 years supervisory experience. Demonstrated management and decision making skills required. Knowledge & Skills: Well versed in all aspects of clinical labeling and packaging, cGMPs and other regulatory requirements pertaining to clinical supplies. Demonstrated project management skills. Must possess experience managing multiple, complex clinical supplies projects simultaneously. Must possess strong problem solving skills using creative and innovative thought. Must have attention to detail. Excellent organizational, written and oral communication skills. Comfortable in working with MS Word, Excel and flow diagramming software. Knowledge & Skills Desirable but Not Essential: Experience with planning software such as MS Project, material flow management tools and Materials Requirements Planning (MRP). Knowledge of package design and materials; label generation software; batch record design. Ability to read, write and understand French.

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